Amlodipine

Product NDC: 33342-015
11-digit product format: 333420015
Labeler code: 33342
Product ID: 33342-015_cf534093-9769-44f3-8570-337fad041447
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Macleods Pharmaceuticals Limited
Application: ANDA201380
Marketing category: ANDA
Marketing start: 2012-04-13
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE
Active strength: 5 mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33342-015		D	Discontinued by firm	2026-07-31
excluded package	package	33342-015	33342-015-10	D	Discontinued by firm	2026-07-31
excluded package	package	33342-015	33342-015-12	D	Discontinued by firm	2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A201380-001	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13
A201380-002	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13
A201380-003	AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2026-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A201380-001	AB
A201380-002	AB
A201380-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A201380-001	AMLODIPINE BESYLATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201380-002	AMLODIPINE BESYLATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-04-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201380-003	AMLODIPINE BESYLATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2026-02-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201380-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201380-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201380-003	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33342-015-10	EA - Each	33342-015	eb8818ce-ca5f-4142-aa98-9ee0e89713de	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE (AMLODIPINE ) TABLET [MACLEODS PHARMACEUTICALS LIMITED]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
1J444QC288	AMLODIPINE	88150-42-9	Amlodipine